FDA Medical Device Recalls (openFDA)
TriMed Inc.: Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
- Recall number
- Z-0932-2024
- Recalling firm
- TriMed Inc.
- Product
- Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
- Status
- Open, Classified
- Initiated
- 2023-11-28
- Posted
- 2024-01-31
- Terminated
- not on file
- Reason
- Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
- Root cause
- Labeling design
- Action
- On 11/28/23, recall notices were emailed to customers who were asked to do the following: 1) Stop further use of the device and return any unused products to the recalling firm. 2) Provide a copy of this recall notice to the hospital/surgeon/physician that is using the device. 3) Complete and return the response form to quality@trimedortho.com Contact quality@trimedortho.com for any additional questions.
- Quantity
- 270
- Distribution
- US: FL, MI, AL, NY, CA
- Lot, serial or model codes
- REF/UDI-DI/Lots: VBEAL-3-7N/00842188124907/ME23071, ME23072; VBEAL-5-7N/00842188124914/ME23073; VBEAL-3-7S/00842188124938/ME23031, ME23067, ME23082, ME23097; VBEAL-5-7S/00842188124945/ME23068; VBEAL-7-7S/00842188124952/ME23004, ME23086; VBEAL-3-7W/00842188124969/ME23033; VBEAL-5-7W/00842188124976/ME23036; VBEAR-3-7N/00842188124990/ME23069, ME23084, ME23085; VBEAR-5-7-N/00842188125003/ME23074; VBEAR-3-7S/00842188125027/ME23029, ME23087; VBEAR-5-7S/00842188125034/ME23019; VBEAR-7-7S/00842188125041/ME23022; VBEAR-3-7W/00842188125058/ME23034; VBEAR-5-7W/00842188125065/ME23041, ME23037
- 510(k) numbers
- K222637
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3001236812
- Firm city
- Santa Clarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28